The US Food and Drug Administration (FDA) warned that Botox® which is used for cosmetic purposes such as wrinkle removal can cause serious side effects, such as death, in severe cases.
The US FDA said that a side effect of muscle paralysis in areas other than an area injected with Botox® was reported and persons injected with Botox® were hospitalized or died.
In addition, the US FDA said that patients in which serious Botox® side effects occurred were mostly child patients whose leg muscles were injected with Botox® in order to treat muscular stiffness caused by cerebral palsy.
Botox® is widely used for the treatment of the muscles of cerebral palsy patients, neck muscle stiffness, pain caused by muscular stiffness, and vocal cord palsy. In the field of cosmetic therapy, Botox® is used for the removal of wrinkles and the prevention or treatment of aging. As anti-aging therapies have recently been popularized, the amount of Botox® used has increased annually.
When Botox® is injected into muscles, the muscular nerves are paralyzed. Thus, Botox® has been injected into children with cerebral palsy whose leg muscles are excessively stiff, in order to make walking more natural.
The FDA considers that Botox® influences respiratory muscle function while spreading to areas other than legs, thereby causing side effects [FDA NEWS RELEASE FOR IMMEDIATE RELEASE Apr. 30, 2009, FDA Patient Safety News: Show #74, April 2008]. In connection with this, the FDA said that patients and doctors need to pay attention to whether a decrease in breathing rate or difficulty in swallowing occurs after injection with Botox® [FDA-approved Patient Labeling Jul. 31, 2009 APPENDIX 1: MEDICATION GUIDE BOTOX, BOTOX Cosmetic (Boe-tox®) (on a botulinum toxin A) for Injection)].
However, the FDA said that a serious side effect of Botox® injection for cosmetic purposes such as wrinkle removal has not yet been reported. The FDA did not require doctors to stop Botox® treatments for cosmetic purposes.
The US consumers union asked the FDA to strengthen the warning that 180 cases of Botox®-related side effects were reported to the FDA between the years 1997 and 2006 and 16 cases thereof led to death and that the use of Botox® can cause abnormalities.
In prior art, botulinum toxin has been purified by performing acid precipitation (U.S. Pat. No. 7,354,740, entitled “Animal product free system and process for purifying a botulinum toxin”, Allergan, Inc.) or performing chromatography following acid precipitation (U.S. Pat. No. 7,452,697, entitled “Chromatographic method and system for purifying a botulinum toxin”, Allergan, Inc; Korean Patent Application No. 10-2008-0016800, entitled “Method of purifying botulinum toxin from Clostridium botulinum, Medexgen Inc.; Korean Patent Application No. 10-2002-0000685, entitled “Method for purifying Clostridium botulinum type A toxin”, Medexgen Inc.).
However, it is known that the botulinum toxins purified by the above methods significantly spread to areas in the body other than the injected area to paralyze the surrounding organs or respiratory muscles, and in severe cases, cause serious side effects leading to death.